Director – Clinical Compliance and Oversight

Director – Clinical Compliance and Oversight

Requirements

• Bachelor’s degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
• At least 10 years of experience in clinical research with direct clinical compliance oversight and leading market inspection experience (eg. FDA, EMA, MHRA, or PMDA)
• Ability to identify areas for process improvement and lead discussions to implement change
• Excellent written and oral communication skills
• Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
• Good organizational skills for the management of clinical development compliance and working in a fast-paced environment
• Strong understanding of best practices as it pertains to vendor governance, site oversight, team training, and trial master file setup and maintenance
• Proficiency with word processing, spreadsheet, database, presentation software (i.e. MS Office skills such as Outlook, Word, Excel, and PowerPoint)
• Proven ability to lead and develop teams, managing complex projects and solving abstract problems
• Demonstrated ability to drive contract execution with aggressive timelines
• Strong communication and negotiation skills, with experience influencing stakeholders and aligning organizational objectives
• Demonstrated ability to set strategic direction and translate it into actionable plans
• High emotional intelligence, with skills in conflict resolution and understanding diverse perspectives
• Experience in budget management and accountability for departmental or cross-functional finances
• Ability to bring structure to ambiguous situations and develop overarching frameworks for projects.

Responsibilities

• Ensure clinical trials comply with global regulations, ICH/GCP, and internal processes by collaborating across Clinical Development
• Review study documents, workflows, and outputs; provide guidance on remediation, training, and continuous process improvement
• Monitor regulatory developments and evolving best practices; address compliance questions and advise on risk mitigation strategies
• Identify and remediate quality issues through root cause analysis, CAPA development and management, and effectiveness checks
• Track and report key risk and quality indicators (KRIs/KQIs) across Clinical Development
• Maintain a robust compliance training program and support inspection readiness and audit activities in partnership with Quality
• Develop and execute vendor management strategies aligned with company goals to drive quality, innovation, and operational efficiency
• Oversee vendor outsourcing processes including RFPs, bid reviews, selection, contracting, budgeting, and performance monitoring
• Implement governance frameworks (KPIs, scorecards, escalation procedures) to ensure consistent vendor oversight across the portfolio
• Partner with Legal on contract negotiations, change orders, and PO lifecycle management
• Develop site oversight strategies and ensure inspection readiness across clinical programs
• Lead TMF oversight in an outsourced/hybrid model to ensure compliance with regulatory requirements and internal SOPs
• Support regulatory inspection activities from preparation through post-inspection follow-up
• Own budget planning and financial oversight, leveraging data to optimize resources and ensure fiscal responsibility
• Drive strategic decision-making through data insights, cross-functional collaboration, and solution-oriented thinking
• Lead change initiatives, ensuring smooth transitions while fostering sustainable growth and innovation
• Build and mentor high-performing teams by promoting a collaborative, inclusive culture grounded in company values
• Support professional development, set clear expectations, deliver feedback, and develop future leaders
• Other duties as assigned.

Preferred Qualifications

No preferred qualifications provided.